The Effect of Physiotherapy for the Treatment of Fecal Incontinence.

NCT01705535 | Unknown

• 1 other identifier: H-2-2012-067
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Fecal incontinence is the complaint of involuntary loss of feces. Fecal incontinence affects 2-12% of the adult population. It is a hidden problem - less than one third of the affected persons discuss the problem with their doctor. The condition has a negative effect on quality of life. It is associated with shame and limitation in social life, leisure, occupational and sexual activities. Pelvic floor muscle exercises with or without the use of biofeedback has been recommended and used for the treatment of fecal incontinence over the last decades. Several uncontrolled trials and some controlled trials have shown a positive effect of this training, but most of the trials are small and/or have methodological problems. Therefore there is to day still a lack of sufficient evidence for the effect of pelvic floor muscle exercise as a treatment of fecal incontinence. The aim of this study is to compare the effect of an individual physiotherapeutic supervised pelvic floor muscle training program with a control physiotherapeutic treatment (massage of the neck and back). Both treatments will be given parallel with standard information and guidance given by a nurse specialized in anal incontinence issues. Study hypothesis: Pelvic floor muscle exercises given parallel with standard advice and guidance by a specialized nurse, provides better effect to reducing fecal incontinence than control treatment and standard advice alone.

Conditions

Fecal Incontinence

Keywords

Fecal incontinence; Pelvic floor muscle exercises; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Improvement Scale (PGI-I Scale)

  Patients are asked to compare their incontinence symptoms before and after treatment and to rate changes on a seven point scale.

  Within 2 weeks after completion of intervention (16 weeks post baseline, primary analysis) Futher assessment: 12 month (follow-up).

Secondary Outcomes (6)

• Fecal Incontinence Severity Index

  Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).

• St. Marks Incontinence Score (Vaizey Score)

  Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).

• Anal manometry

  Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).

• Rectal capacity measurement

  Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).

• Incontinence dairy

  Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).

Other Outcomes (1)

• Training diary

  During intervention and again at follow-up 1 year after completion of the intervention.

Study Arms (2)

Pelvic floor muscle exercises

EXPERIMENTAL

Individual supervised pelvic floor muscle exercises. Standard information and guidance

Behavioral: Individual supervised pelvic floor muscle exercises; Behavioral: Standard information and guidance

Masage of the neck and back

ACTIVE COMPARATOR

Massage of the neck and back. Standard information and guidance

Other: Massage of the neck and back; Behavioral: Standard information and guidance

Interventions

Individual supervised pelvic floor muscle exercises BEHAVIORAL

Six individual treatments of 45 minutes by a physiotherapist specialized in pelvic floor disorders. Preparation of an individual adapted training program for the pelvic floor muscles. Encouragement to perform the pelvic floor muscle training program on a daily basis

Also known as: Pelvic floor muscle training, Physiotherapy

Pelvic floor muscle exercises

Massage of the neck and back OTHER

six individual treatments of 30 minutes by a physiotherapist. The participants will get no instructions of pelvic floor muscle exercises.

Masage of the neck and back

Standard information and guidance BEHAVIORAL

Advice about diet and fiber supplements. Information about optimizing bowel emptying including use of medicine. Advice about use of antidiarrheal medication if appropriate.

Masage of the neck and back; Pelvic floor muscle exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients refered to examination and treatment of fecal incontinence at the Department of surgical and medical Gastroenterology at Hvidovre University Hospital.
• Duration of fecal incontinence for at least 6 month.

You may not qualify if:

• Participants who has received more than 2 sessions of individual instructions of pelvic floor muscle exercises by a physiotherapist during the last 12 month.
• Chronic diarrhea
• Severe neurological disorders (multiple sclerosis, parkinsons, spinal cord injury,stroke or neuromuscular junction disease.
• Rectal prolapse
• Previously cancer operation or radiotherapy in the lower abdomen
• Linguistically and/or cognitively incapable of understanding how to perform the pelvic floor muscle training program
• Pregnancy

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Department of Physiotherapy, Hvidovre University Hospital

Copenhagen, DK-2650 Hvidovre, Denmark

Location

Related Publications (1)

• Ussing A, Dahn I, Due U, Sorensen M, Petersen J, Bandholm T. Efficacy of Supervised Pelvic Floor Muscle Training and Biofeedback vs Attention-Control Treatment in Adults With Fecal Incontinence. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2253-2261.e4. doi: 10.1016/j.cgh.2018.12.015. Epub 2018 Dec 20.

  PMID: 30580089 DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Physical Therapy Modalities; Counseling

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anja Ussing

  Hvidovre University Hospital Denmark, Department of Physiotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 12, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

DK (1)